Non-invasive surgery to attach a medical implant within the body, e.g., within the interior of a hollow organ such as the stomach, has become an important surgical option. For example, bariatric surgery to limit food intake into the stomach, in the treatment of obesity, can now be done transorally, rather than having to penetrate the peritoneal cavity. In a transoral procedure, an access tube is placed in the patient's esophagus, as a guide for one more or more endoscopic tools used in attaching an implant to, and/or reconfiguring, the stomach.
An anatomical view of a human stomach S and associated features is shown in FIG. 1. The esophagus E delivers food from the mouth to the proximal portion of the stomach S. The z-line or gastro-esophageal junction Z is the irregularly-shaped border between the thin tissue of the esophagus and the thicker tissue of the stomach wall. The gastro-esophageal junction region G is the region encompassing the distal portion of the esophagus E, the z-line, and the proximal portion of the stomach S.
Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
Several prior applications, including U.S. Publication No. US 2007/0276432; having a priority date of Oct. 8, 2004 and U.S. Publication No. US 2008/0065122, filed May 23, 2006 describe methods according to which medical implants are coupled to tissue structures, such as plications or folds, formed within the stomach. Examples of methods and devices for forming such tissue structures are described in U.S. Publication No. US 2007/0219571 (entitled ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S. application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser. No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS), filed Mar. 18, 2008. Each of the referenced publications and applications is incorporated herein by reference.
As disclosed in these prior applications, more robust and long lasting coupling between the implant and the surrounding stomach wall tissue is achieved when the plications/folds are formed by retaining regions of serosal tissue (i.e., the tissue on the exterior surface of the stomach) in contact with one another. Over time, adhesions form between the opposed serosal layers. These adhesions help to create strong bonds that can facilitate retention of the plication fold over extended durations, despite the forces imparted on them by stomach movement and implanted devices
Several of the disclosed methods for forming tissue plications include a step in which a hole or cut is formed in the plication, using the plication forming device or a separate tissue-cutting device. Typically, the device also fastens the fold with an array of staples that are formed in the tissue about the hole. An example of this type of stapled tissue plication is shown in FIG. 2A, which is a cross-section taken along line 2B-2B in FIG. 1. Stapling devices and methods for forming such stapled tissue folds of this type are described in co-owned U.S. application Ser. No. 11/542,457, entitled ENDOSCOPIC PLICATION DEVICES AND METHODS, filed Oct. 3, 2006, and published Sep. 20, 2007 as US 2007-0219571, and co-owned U.S. application Ser. No. 12/050,169, entitled ENDOSCOPIC STAPLING DEVICES AND METHODS, filed Mar. 18, 2008, both and incorporated herein by reference.
In a typical procedure that uses the stapled plications for implant attachment, a plurality of stapled tissue plications, each with an anchor-receiving hole, are formed in a tissue, such as illustrated in FIGS. 2A and 2B. In the latter figure, five such plications are formed in the interior of the stomach, for attaching a food-restrictive pouch, or restrictor, near a patient's esophagus, to limiting food intake by the patient. After formation of the plications, an anchor (FIG. 2C) is placed in each hole (FIG. 2D), and the implant, e.g., restrictor, is attached to the plications by introducing, for each plication, an anchor that extends through the hole and through an anchor-receiving aperture in the implant (FIG. 2E). By way of illustration, for placement of a stomach restrictor attached to five plications formed within the stomach (FIG. 2F), the implant operation will require ten separate steps in which an endoscopic device is placed in and then removed from the stomach transorally: five for forming each of the stomach plications, and five for each anchor placement between a plication and anchor-receiving aperture in the restrictor. A system and method for implanting a food-restrictive device of this type are detailed in co-owned U.S. application Ser. No. 12/175,242, filed Jul. 17, 2008, corresponding to PCT application PCT/US2008/008729, which is incorporated herein in its entirety.
Given the surgical time and inconvenience, and the patient discomfort, associated with each transoral-accessing step, it would be desirable to reduce the number of accessing steps needed for attaching an implant to a tissue plication. Co-owned U.S. patent application Ser. No. 12/434,226 for PLICATION TAGGING DEVICE AND METHOD, filed May 1, 2009, discloses a device and method for placing an anchor in the plication at the time the plication is formed, thus reducing to five the number of accessing steps needed to place five tissue-attached anchors within the stomach. The present application discloses a device and method capable of accessing a plurality of spaced targets within the organ, such as the five tissue-supported anchors, and optionally, for attaching an implant to the targets in a single accessing step.